Z-2490-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- July 12, 2019
- Termination Date
- June 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 307 kits
Product Description
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Reason for Recall
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
Distribution Pattern
Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Code Information
Lot Numbers: 961UE onwards GTN: 05055273200966